Technical note Demonstrating column robustness through simulated transport testing Astrea Bioseparations performed transportation testing using an Evolve®D pre-packed chromatography column to evaluate the impact of simulated shipping and handling conditions on column integrity and chromatographic performance. Testing included vibration, shock, drop, and handling simulations representative of global air freight, sea, and road transport. Column performance assessments conducted before and after simulation testing demonstrated minimal variation in key chromatographic parameters, confirming maintained packing integrity, operational robustness, and suitability for shipment using Astrea Bioseparations’ dedicated transport packaging solutions.
Introduction Pre-packed chromatography columns are offered as part of Astrea Bioseparations’ extensive column product range. Designed for direct integration, these columns are supplied ready-for-use with certified performance to meet customer’s acceptance criteria. Maintaining column integrity is critical to ensuring consistent chromatographic performance upon arrival. Transportation by sea, air, or road can expose the packed column to vibration, shock and impact stresses. ISTA transportation testing allows assessment of these effects on the packed bed integrity and column performance criteria by evaluating column efficiency before and after the simulated testing procedures.
Demonstrating packed bed integrity and column performance using simulated transportation effects Astrea Bioseparations’ dispatched a pre-packed Evolve®D 35 cm & 60 cm chromatography column packed with an agarosebased resin to an accredited independent testing facility for ISTA transportation testing. The International Safe Transit Association (ISTA) protocols are industry standard protocols designed to simulate the environmental and mechanical stresses encountered during transportation and handling.
250 mm (2.5-19.6 L)
300 mm (3.5-28.3 L)
350 mm (4.8-38.5 L)
Testing conditions are designed to challenge the shipping configuration of the packaged product and packaging integrity during transportation, and includes: • Controlled vibration testing • Shock and impact events to represent potential handling incidents during loading and unloading • Compression and movement assessments to evaluate packaging protection during transit
Impact of transportation on packed bed performance By evaluating chromatographic performance before and after ISTA testing, the study can be used to assess the impact of transportation conditions on packed bed integrity, confirming maintained packing quality and operational performance following simulated shipment. Bed stability and packing integrity are considered maintained when the following performance characteristics remain uncompromised: • Column efficiency and plate count • Peak shape and degree of symmetry • Pressure-flow characteristics
450 mm (8.0-63.6 L)
600 mm (14.1-113.1 L)
Key performance indicators measured for the 35 cm Evolve®D column: P
Pre-ISTA testing
Post-ISTA testing
Bed height
20 cm
20 cm
HETP
0.020 cm
0.019 cm
Asymmetry factor
1.2
1.31
Plate count per meter
5038
5329
Pressure at test flow rate
0.56 bar
0.48 bar
Figure 1: Pre-ISTA testing column analysis chromatogram for the 35 cm column.
Figure 2: Post-ISTA testing column analysis chromatogram for the 35 cm column.
Key performance indicators measured for the 60 cm Evolve®D column: P
Pre-ISTA testing
Post-ISTA testing
Bed height
20 cm
20 cm
HETP
0.03 cm
0.03 cm
Asymmetry factor
1.0
1.0
Plate count per meter
3537
3614
Pressure at test flow rate
0.9 bar
0.8 bar
Figure 3: Pre-ISTA testing column analysis chromatogram on the 60 cm column.
Figure 4: Post-ISTA testing column analysis chromatogram on the 60 cm column.
Column performance was evaluated using standard column performance analysis methods.
Impact of transportation on packed bed performance
The acceptance criteria for the resin used in this study are presented below.
The Evolve®D 35 cm & 60 cm pre-packed chromatography columns both successfully maintained chromatographic performance following ISTA transportation testing.
Acceptance criteria Number of plates/m
HETP
Asymmetry
>2000
<0.1
0.8-1.8
Chromotographic evaluation conducted prior to ISTA testing confirmed that both columns met the defined acceptance criteria (Figure 1 & figure 3). Comparable chromatographic performance was observed after ISTA testing (Figure 2 & figure 4) demonstrating consistent peak shape, plate count, HETP, and asymmetry values demonstrating that the packed bed integrity was maintained following simulated transportation.
Minimal variation was observed across all performance indicators when performance values were compared, demonstrating that the column packing was robust and suitable for global shipment. While the study was performed using the 35 cm & 60 cm Evolve®D pre-packed columns, the transportation validation approach and packaging configuration are representative of Astrea Bioseparations’ broader large scale pre-packed column platform, supporting transportation robustness across larger column formats. This testing demonstrates Astrea Bioseparations’ commitment to delivering pre-packed chromatography solutions that arrive ready to use while maintaining high performance standards throughout any transportation and handling events.
Astrea Bioseparations is a world class provider of chromatography adsorbent and resin services. With over 30 years of chromatography manufacturing expertise, we deliver a unique and trusted service in close partnership with our clients. For more information, please don’t hesitate to reach out at sales@astrea-bio.com or visit astreabioseparations.com. Any data or results provided are only examples and do not provide any guarantee of similar results in future. The products of Astrea Bioseparations may be covered by or for use under one or more patents: astreabioseparations.com/patents All trademarks, trade names, trade dress, product names and logos are the property of Astrea UK Services Ltd or their respective owners. @2026 Astrea Bioseparations Ltd. All rights reserved.